DANTRIUM Powder for solution for injection Ref.[8168] Active ingredients: Dantrolene

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Norgine Pharmaceuticals Limited, Norgine House, Widerwater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK

Product name and form

Dantrium IV 20mg.

Pharmaceutical Form

Powder for solution for injection.

Qualitative and quantitative composition

Each vial contains 20mg dantrolene sodium.

For the full list of excipients, see 6.1.

Active Ingredient Description
Dantrolene

The receptor molecule for dantrolene has not been identified. Dantrolene inhibits the binding of ryanodine. Under some conditions, dantrolene will lower intra-sarcoplasmic calcium concentrations in the resting state. This may be more important in diseased muscle (e.g. In malignant hyperthermia in humans and swine stress syndrome) than in muscle with normal function.

List of Excipients

Mannitol
Sodium hydroxide

Pack sizes and marketing

Type I glass vial with chlorobutyl rubber stopper with aluminium seal. Each vial is provided with a single-use filtration device. Supplied in packs of 12 or 36 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Norgine Pharmaceuticals Limited, Norgine House, Widerwater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK

Marketing authorization dates and numbers

PL 20011/0034

14/02/1980

Drugs

Drug Countries
DANTRIUM Australia, Canada, Estonia, France, Ireland, Japan, Malta, Netherlands, New Zealand, Romania, United Kingdom, United States, South Africa

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